Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder (POLARIS)

AstraZeneca

Status: Terminated

Conditions: Sub-syndromal Symptoms; Bipolar Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT01663974

NIS-NFR-XXX-2012/1

Details and patient eligibility

About

The study aims to evaluate:

• the frequency of subsyndromal symptoms or disorders observed during interepisode phases in bipolar patients, particularly after a depressive episode in which these subsyndromal disorders are the most frequent
• the functional impact of these disorders, factors or symptom thresholds associated with functional remission, and factors associated with symptomatic remission over a sufficient follow-up (12 months).

Full description

Evaluation of sub-syndromal symptoms after acute depressive episode in bipolar disorder

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient with a diagnosis of bipolar disorder according to DSM-IV criteria currently followed up by the investigator in hospital or open-care practice and informed of his/her disease.
• For whom the previous episode was a bipolar depression assessed clinically stabilized for at least 4 weeks by the investigator.
• Able to complete the self-assessment diary weekly

Exclusion criteria

• Pregnant women.
• Patient included in a clinical trial on an investigational drug or having received an investigational drug in the preceding 30 days.
• Person deprived of freedom or subject to a guardianship (or ward) order or unable to undergo medical monitoring for geographical, social or psychological reasons.

Trial design

125 participants in 1 patient group

Bipolar disorder patients